Heywood R
St. George's House, Huntingdon, Cambridge, UK.
Int J Gynaecol Obstet. 1995 Dec;51 Suppl 1:S41-5. doi: 10.1016/0020-7292(95)90368-2.
There are no guidelines regulating the technologies available for Fallopian tube occlusion. Generally accepted regulatory requirements cannot be applied directly to the safety assessment of these technologies. The more appropriate guidelines are those regulating medical devices. Each method has to be evaluated on its own merits taking into consideration the duration of contact with tissue and the chemical and physical composition of the occlusive agents.
目前尚无规范输卵管闭塞可用技术的指南。普遍认可的监管要求不能直接应用于这些技术的安全性评估。更合适的指南是那些规范医疗器械的指南。每种方法都必须根据其自身优点进行评估，同时要考虑与组织接触的持续时间以及闭塞剂的化学和物理成分。
